Resumen

This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator's choice) and cyclophosphamide alone in patients with Stage II-III TNBC (Triple Negative Breast Cancer)

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Non-metastatic operable Stage II-III breast cancer
Histologically documented TNBC (Triple Negative Breast Cancer)
Confirmed tumor PD-L1 evaluation as documented through central testing of a representative tumor tissue specimen
Adequately excised: Patients must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy
Adequate hematologic and end-organ function
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm.
No more than 8 weeks (56 days) may elapse between definitive breast surgery and randomization.
Representative formalin-fixed, paraffin embedded (FFPE) tumor specimen from surgical resection in paraffin blocks (preferred) or at least 25 unstained slides.

Criterios de exclusión

Prior history of invasive breast cancer
For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (e.g., neoadjuvant or adjuvant), including, but not limited to, chemotherapy, anti-HER2 therapy.
Previous therapy with anthracyclines or taxanes for any malignancy
Cardiopulmonary dysfunction
Prior malignancies within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
Active or history of autoimmune disease or immune deficiency
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
Urinary outflow obstruction
Active tuberculosis
Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during study treatment or within 5 months following the last dose of Atezolizumab (for patients randomized to Atezolizumab)
Prior allogeneic stem cell or solid organ transplant
Treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressive medication during the study

Intervenciones

drug

Atezolizumab

Atezolizumab will be administered by IV, 840 mg every 2 weeks, for 10 doses. Atezolizumab maintenance will be administered by IV, 1200 mg every 3 weeks to complete 1 year

drug

Paclitaxel

Paclitaxel will be administered by IV, 80 mg/m\^2 every week for 12 weeks.

drug

Dose-dense Doxorubicin or dose-dense Epirubicin

Dose-dense doxorubicin will be administered by IV, 60 mg/m\^2 every 2 weeks for a total of 4 doses. Or Dose-dense epirubicin will be administered by IV, (90 mg/m\^2) every 2 weeks for a total of 4 doses

drug

Cyclophosphamide

Cyclophosphamide will be administered by IV, 600 mg/m\^2 every 2 weeks for 4 doses

Ubicaciones

Centro de Oncologia e; Investigacion Buenos Aires - COIBA

Berazategui, Argentina

INSTITUTO DE INVESTIGACIONES METABOLICAS (IDIM); Oncology

Ciudad Autonoma Buenos Aires, Argentina

Hospital Britanico de Buenos Aires

Ciudad Autonoma Buenos Aires, Argentina

Clinica Universitaria Reina Fabiola

Córdoba, Argentina

Centro Oncologico Riojano Integral (CORI)

La Rioja, Argentina

Instituto de Oncología de Rosario

Rosario, Argentina

Centro Medico San Roque

San Miguel de Tucumán, Argentina

Fundación Ars Medica

San Salvador de Jujuy, Argentina

Centro de Investigacion Clinica - Clinica Viedma S.A.; Oncology Department

Viedma, Argentina

A Phase III, Multicenter, Randomized, Open-Label Study Comparing Atezolizumab (Anti PD-L1 Antibody) in Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone in Patients With Operable Triple Negative Breast Cancer

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Atezolizumab

Paclitaxel

Dose-dense Doxorubicin or dose-dense Epirubicin

Cyclophosphamide

Ubicaciones

Centro de Oncologia e; Investigacion Buenos Aires - COIBA

INSTITUTO DE INVESTIGACIONES METABOLICAS (IDIM); Oncology

Hospital Britanico de Buenos Aires

Clinica Universitaria Reina Fabiola

Centro Oncologico Riojano Integral (CORI)

Instituto de Oncología de Rosario

Centro Medico San Roque

Fundación Ars Medica

Centro de Investigacion Clinica - Clinica Viedma S.A.; Oncology Department

Patrocinadores